DETAILED ACTION
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Specification
The disclosure is objected to because it contains an embedded hyperlink and/or other form of browser-executable code. Applicant is required to delete the embedded hyperlink and/or other form of browser-executable code; references to websites should be limited to the top-level domain name without any prefix such as http:// or other browser-executable code. See MPEP § 608.01. The last entry on the citation list, at the end of the specification, includes a hyperlink.
Claim Objections
Claim 1 is objected to because of the following informalities: since humans are animals, there is no need to further state “including a human.” Appropriate correction is required.
Claims 7 and 17 are objected to because of the following informalities: it appears as though the exponents were not properly formatted; it is assumed that the first two digits of the numbers in the claims are the base and the next digit(s) are the exponent (e.g. 105 should be 105). Additionally, “cells” is interpreted to be equivalent to CFU. Appropriate correction is required.
Claim 15 is objected to because of the following informalities: semaglutide, liraglutide, orlistat, naltrexone, bupropion, and setmelanotide are not proper nouns and do not need to be capitalized. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 7, and 12-16 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Regarding claims 7 and 12-16, phrases like "such as," and “in particular render the claims indefinite because they are unclear whether the limitations following the phrases are part of the claimed invention. See MPEP § 2173.05(d).
The following is a quotation of 35 U.S.C. 112(d):
(d) REFERENCE IN DEPENDENT FORMS.—Subject to subsection (e), a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
The following is a quotation of pre-AIA 35 U.S.C. 112, fourth paragraph:
Subject to the following paragraph [i.e., the fifth paragraph of pre-AIA 35 U.S.C. 112], a claim in dependent form shall contain a reference to a claim previously set forth and then specify a further limitation of the subject matter claimed. A claim in dependent form shall be construed to incorporate by reference all the limitations of the claim to which it refers.
Claim 8 is rejected under 35 U.S.C. 112(d) or pre-AIA 35 U.S.C. 112, 4th paragraph, as being of improper dependent form for failing to further limit the subject matter of the claim upon which it depends, or for failing to include all the limitations of the claim upon which it depends. The claim provides for a step of administering the claimed microbe, but this administering limitation is no different than that of the parent claim; in fact, the wording used in claim 8 is nearly identical to the wording used in the parent claim. Applicant may cancel the claim(s), amend the claim(s) to place the claim(s) in proper dependent form, rewrite the claim(s) in independent form, or present a sufficient showing that the dependent claim(s) complies with the statutory requirements.
Claim Rejections - 35 USC § 102
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
Claims 1-12 are rejected under 35 U.S.C. 102(a)(1) as being anticipated by Yavorov-Dayliev, et al (Food & Function, 14, 10855-10867, 2023). It is noted that there is an overlap between some of named inventors and some of the named authors; however, since there is a difference, the provided prior art is considered to be written by an entity that is different than the named Applicants. Since the cited prior art is within the one-year grace period, if the Applicants can provide the appropriate documentation to correct/ensure ownership, this reference can potentially be eliminated as viable prior art. See MPEP 2153.01(a).
Yavorov-Dayliev teaches a method of treating obesity by providing subjects with an effective amount of Pediococcus acidilactici. See page 10855, “Abstract” section. Yavorov-Dayliev’s amount of P. acidilactici must have been “effective,” since the method provided treatment in the context of the claimed invention.
With respect to claims 1 and 8, Yavorov-Dayliev teaches the method.
With respect to claims 2 and 9, Yavorov-Dayliev indicates that the test animals were obese, wherein obesity was “treated.” See page 10855, “Abstract” section.
With respect to claims 3-6, Yavorov-Dayliev teaches that the P. acidilactici were lyophilized members of the deposited “9879” strain. See page 10856, “Bacterial strain” and “Experimental diets” section. Since lyophilized bacteria are not animate, as they are not actively metabolizing and dividing, they must necessarily be considered inanimate.
With respect to claim 7, Yavorov-Dayliev provides 1010 CFU (cells) per day, per animal. See page 10856, “Experimental diets” section.
With respect to claims 10-12, Yavorov-Dayliev teaches that the composition was provided orally in the animal’s food. See page 10856, “Experimental diets” section. Based upon the Applicant’s definition of “nutraceutical,” Yavorov-Dayliev method fulfills this definition.
Claim Rejections - 35 USC § 103
In the event the determination of the status of the application as subject to AIA 35 U.S.C. 102 and 103 (or as subject to pre-AIA 35 U.S.C. 102 and 103) is incorrect, any correction of the statutory basis (i.e., changing from AIA to pre-AIA ) for the rejection will not be considered a new ground of rejection if the prior art relied upon, and the rationale supporting the rejection, would be the same under either status.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
The factual inquiries for establishing a background for determining obviousness under 35 U.S.C. 103 are summarized as follows:
1. Determining the scope and contents of the prior art.
2. Ascertaining the differences between the prior art and the claims at issue.
3. Resolving the level of ordinary skill in the pertinent art.
4. Considering objective evidence present in the application indicating obviousness or nonobviousness.
This application currently names joint inventors. In considering patentability of the claims the examiner presumes that the subject matter of the various claims was commonly owned as of the effective filing date of the claimed invention(s) absent any evidence to the contrary. Applicant is advised of the obligation under 37 CFR 1.56 to point out the inventor and effective filing dates of each claim that was not commonly owned as of the effective filing date of the later invention in order for the examiner to consider the applicability of 35 U.S.C. 102(b)(2)(C) for any potential 35 U.S.C. 102(a)(2) prior art against the later invention.
Claims 13-20 are rejected under 35 U.S.C. 103 as being unpatentable over Yavorov-Dayliev, et al (Food & Function, 14, 10855-10867, 2023) and Chen, et al (Biological Trace Element Research, 52, 125-132, 1996). See the discussion of Yavorov-Dayliev, above. Yavorov-Dayliev does not teach further including compounds like zinc. While it is noted that Yavorov-Dayliev does not teach or suggest other compounds to treat/prevent obesity, the ordinary artisan possesses ample knowledge of the field, wherein the ordinary artisan possesses a Masters, PhD, or MD, and possesses applied knowledge regarding obesity and animal metabolism. As such, the ordinary artisan would likely suggest other activities or compounds that are known to treat obesity, as these are obvious to try measures. See MPEP 2141.03.
Chen provides methods of treating obesity in mice by providing zinc supplementation. See page 125, “Abstract” section. As discussed above, the ordinary artisan who possesses a reasonable amount of knowledge if the instantly claimed field. There is nothing non-obvious about providing multiple obesity treating compounds, since multiple compounds would be expected to be more effective than an individual obesity-treating compound.
With respect to claim 13, Chen provides motivation to include zinc in a method of treating obesity. As discuseed above, Yavorov-Dayliev teaches that the P. acidilactici were lyophilized members of the deposited “9879” strain. See page 10856, “Bacterial strain” and “Experimental diets” section. Since lyophilized bacteria are not animate, as they are not actively metabolizing and dividing, they must necessarily be considered inanimate.
With respect to claim 14, Yavorov-Dayliev teaches a lyophilized form of the 9879 strain and Chen teaches zinc. Since both the lyophilized P. acidilactici and zinc have been shown to enhance methods of treating obesity, there is reasonable implicit motivation to combine the methods, wherein the ordinary artisan would expect that the obesity-treating compounds would provide for additive improvements over each individual treatment.
With respect to claim 15, as discussed above, it would be obvious to the ordinary artisan to provide a combined treatment for treating obesity. There is nothing non-obvious about increasing exercise level, or decreasing calorie consumption, as a means of treating obesity.
With respect to claim 16, Chen teaches zinc provides for obesity treatment. Since there is clear motivation found in the art and knowledge of the ordinary artisan to provide for a combination treatment, the instant claim is considered obvious.
With respect to claim 17, Chen appears to suggest a range for zinc that overlaps with the claimed range. See page 127, Table 1. As discussed above, Yavorov-Dayliev teaches the clamed number of cells (CFU).
With respect to claim 18, Yavorov-Dayliev teaches that the P. acidilactici were lyophilized members of the deposited “9879” strain. See page 10856, “Bacterial strain” and “Experimental diets” section. Since lyophilized bacteria are not animate, as they are not actively metabolizing and dividing, they must necessarily be considered inanimate.
With respect to claim 19, Yavorov-Dayliev and Chen both teach treating obesity/overweight.
With respect to claim 20, since the claim does not appear to care when the zinc is consumed, the coadministration of the claimed microbe with zinc would be obvious to the ordinary artisan. Determining the time frame for administration of the two ingredients would be a matter of routine testing that could easily be accomplished by the ordinary artisan.
Double Patenting
The nonstatutory double patenting rejection is based on a judicially created doctrine grounded in public policy (a policy reflected in the statute) so as to prevent the unjustified or improper timewise extension of the “right to exclude” granted by a patent and to prevent possible harassment by multiple assignees. A nonstatutory double patenting rejection is appropriate where the conflicting claims are not identical, but at least one examined application claim is not patentably distinct from the reference claim(s) because the examined application claim is either anticipated by, or would have been obvious over, the reference claim(s). See, e.g., In re Berg, 140 F.3d 1428, 46 USPQ2d 1226 (Fed. Cir. 1998); In re Goodman, 11 F.3d 1046, 29 USPQ2d 2010 (Fed. Cir. 1993); In re Longi, 759 F.2d 887, 225 USPQ 645 (Fed. Cir. 1985); In re Van Ornum, 686 F.2d 937, 214 USPQ 761 (CCPA 1982); In re Vogel, 422 F.2d 438, 164 USPQ 619 (CCPA 1970); In re Thorington, 418 F.2d 528, 163 USPQ 644 (CCPA 1969).
A timely filed terminal disclaimer in compliance with 37 CFR 1.321(c) or 1.321(d) may be used to overcome an actual or provisional rejection based on nonstatutory double patenting provided the reference application or patent either is shown to be commonly owned with the examined application, or claims an invention made as a result of activities undertaken within the scope of a joint research agreement. See MPEP § 717.02 for applications subject to examination under the first inventor to file provisions of the AIA as explained in MPEP § 2159. See MPEP § 2146 et seq. for applications not subject to examination under the first inventor to file provisions of the AIA . A terminal disclaimer must be signed in compliance with 37 CFR 1.321(b).
The filing of a terminal disclaimer by itself is not a complete reply to a nonstatutory double patenting (NSDP) rejection. A complete reply requires that the terminal disclaimer be accompanied by a reply requesting reconsideration of the prior Office action. Even where the NSDP rejection is provisional the reply must be complete. See MPEP § 804, subsection I.B.1. For a reply to a non-final Office action, see 37 CFR 1.111(a). For a reply to final Office action, see 37 CFR 1.113(c). A request for reconsideration while not provided for in 37 CFR 1.113(c) may be filed after final for consideration. See MPEP §§ 706.07(e) and 714.13.
The USPTO Internet website contains terminal disclaimer forms which may be used. Please visit www.uspto.gov/patent/patents-forms. The actual filing date of the application in which the form is filed determines what form (e.g., PTO/SB/25, PTO/SB/26, PTO/AIA /25, or PTO/AIA /26) should be used. A web-based eTerminal Disclaimer may be filled out completely online using web-screens. An eTerminal Disclaimer that meets all requirements is auto-processed and approved immediately upon submission. For more information about eTerminal Disclaimers, refer to www.uspto.gov/patents/apply/applying-online/eterminal-disclaimer.
Claims 1-20 are provisionally rejected on the ground of nonstatutory double patenting as being unpatentable over claims 41-48 of copending Application No. 17/787,270 in view of Yavorov-Dayliev, et al (Food & Function, 14, 10855-10867, 2023). The cited application provides for a method of regulating blood glucose by providing P. acidilactici CECT 9879 to a subject. Yavorov-Dayliev was discussed in the rejections above. When considering the full scope of the cited application, it is noted that the claimed subject-pool would necessarily include subjects that are either obese, or wanting to prevent obesity, because obesity and the desire to prevent/treat obesity is an obvious goal for those with high blood glucose and diabetes. Although the pending claim-set does not teach or suggest treating obesity, Yavorov-Dayliev explicitly teaches the claimed microbe and notes that subjects in the application (in need of blood glucose reduction) would necessarily overlap with subjects that are obese. See page 10862, right column, 1st [incomplete] paragraph.
Based upon this analysis, it appears that the subjects provided in the method of the cited patent would necessarily overlap with the subjects provided in the instant claim-set. Since there is a clear overlap in the methodology and subject-pool, the claims of the cited application, and the instant claim-set provide for non-statutory double patenting.
This is a provisional nonstatutory double patenting rejection.
Conclusion
Any inquiry concerning this communication or earlier communications from the examiner should be directed to DAVID W BERKE-SCHLESSEL whose telephone number is (571)270-3643. The examiner can normally be reached M-F 8AM-5:30PM.
Examiner interviews are available via telephone, in-person, and video conferencing using a USPTO supplied web-based collaboration tool. To schedule an interview, applicant is encouraged to use the USPTO Automated Interview Request (AIR) at http://www.uspto.gov/interviewpractice.
If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Melenie Gordon can be reached at 571-272-8037. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/DAVID W BERKE-SCHLESSEL/Primary Examiner, Art Unit 1651
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